Search Results: 29 vacancies
...and preparing technical reports.
· Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
· Provide support during commissioning phase by reviewing and approving documents...
...Continually seeks to drive improvements in product and process quality.
Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Evaluates new equipment and processes and participates in the transfer of new products....
...with Operations and the business functions to ensure quality performance of product and processes.
~ Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
~ Lead and participate in the development of the internal Lab focusing...
...Supports in the development and upgrade of engineering procedures, template, and forms, to ISO9001 and en1090 standards.
May own and lead CAPA and NCE activities.
Role Requirements:
A degree in a relevant engineering subject is required.
Minimum of 5 years’ experience...
...departmental initiatives where applicable.
· To assist in laboratory investigations as required, in particular Quality Issues, deviations and CAPAs, to help meet specifications and quality timelines.
· To foster a culture of Lean and Continuous improvement within the department...
...accordance with Hovione internal procedures.
Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate.
Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals....
...predictive quality systems which are easily transferable and maintainable in a production environment.
Provide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.
Support Design for Manufacture...
...patient risk.
Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
Oversight and responsibility to ensure site maintains...
...effective and responsive project and QMS support to Operations to resolve in-house, customer and supplier issues.
Own and review NC/CAPA’s related to process.
Interface with Suppliers for planning/quality Issues.
Work cross functionally with such groups as Regulatory...
...training of team members as appropriate.
Carry out and report internal team audits, as appropriate.
Complete assigned tasks and CAPAs as required.
Raise purchase requisitions on SAP as required.
Equivalency testing as per an agreed protocol. Equivalency testing...
Remote job
...and the business functions to ensure quality performance of product and processes.
Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
Initiates and lead in the development and improvement...
...The Day Process engineer will own all Quality and Safety investigations handed over from the shift. They will also own any resulting CAPAs relating to process equipment.
They will identify and assist in the implement equipment process improvements and optimization opportunities...
...transparency and traceability of automation systems.
Participate in risk assessments root cause analyses and corrective/preventive actions (CAPAs) to address automationrelated issues and drive process improvements.
Stay current with industry trends and emerging technologies in...
...deploy strategies for operations.
Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to Packaging Operations.
Interfaces with regulatory agencies as required representing Gilead to authorities...
...ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and...
...exercises judgement to evaluate impact and determines appropriate actions
Review and approval of GMP Deviation investigations and CAPAs
Identifies problems and generates alternatives and recommendations
Completion of routine/non-routine to more complex projects/assignments...
...review meetings, identifying opportunities for improvement.
Manage the Corrective & Preventive Action process and ensure effective CAPA’s are implemented following identification of a root cause and approval from the Quality Manager/RP.
Support external audits with regulatory...
...Management System, such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
Executes the finished product non-conformance process.
Supports document reviews to ensure timely release of finished product....
...validation studies and lifecycle management of Chemistry Assays.
Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
Actively pursue development opportunities to increase the skill set and experience within...
...equipment issues. The Day Process engineer will own all Quality and Safety investigations handed over from the shift. Own any resulting CAPAs relating to process equipment. Identify and assist in the implementation of equipment process improvements and optimization...